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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02453113
Other study ID # 20151840
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date January 2019

Study information

Verified date October 2022
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this is that the researcher can use low power Near Infrared laser treatment non-painful and non-damaging dose to changes the skin properties.The researcher can prove that signaling and a significant increase in the number of skin cells in skin tissue exposed to the laser can improve the human skin immune system to help improve human body response to vaccines.


Description:

The researcher can use low power laser light one-minute exposures delivered to the skin at non-painful and non-damaging dose. The resulted in significant immunologic changes in the skin that included up-regulation of specific skin tissue and skin genes and the activation and mobilization of specific skin cells. In the first part of the study, the researcher will make a determination of the laser irradiance that will be tolerated. The highest irradiance the subject tolerates for 1 minute will be identified as that subject's maximum tolerable irradiance. After all subjects are tested, researcher will select the highest irradiance that was tolerated and use this in the second phase of the study. Approximately 24 hours after the first test exposures, each subject will receive a one minute laser treatment at the maximum tolerable irradiance. Four hours later, two skin biopsies will be collected from laser treated site a untreated. One tissue sample will be test at UC Irvine Dept. of Dermatopathology to evaluate microscopic skin changes, one skin sample will be delivered to Massachusetts General Hospital to evaluate RNA and protein expression.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date January 2019
Est. primary completion date January 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Adult men and women with skin type 1 and 2 - Not pregnant Exclusion Criteria: - Use of systemic steroids, topical steroids, tanning solutions and anticoagulant - History of HIV, mentally incompetent, prisoner, alcohol or drug impairment - Abnormal photosensitivity

Study Design


Related Conditions & MeSH terms


Intervention

Other:
low power laser
Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment

Locations

Country Name City State
United States Vaccine and Immunotherapy Center Massachusetts General Hospital Charlestown Massachusetts
United States Beckman Laser Institute Irvine California

Sponsors (3)

Lead Sponsor Collaborator
University of California, Irvine Beckman Laser Institute University of California Irvine, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Skin Tissue Response to a Vaccine Change in inflammatory cells with low level laser will be measured. up to 12 months
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